Compliance in Non Invasive Mechanical Ventilation | NCT05379309

Studies
Compliance in Non Invasive Mechanical Ventilation

NCT05379309

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

May 18, 2022Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Respiratory Insufficiency

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

May 11, 2022

First Submission Date that Met QC Criteria

May 17, 2022

First Posted Date

May 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen Funderskov, MScN project nurse, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Measure	Description	Time Frame
Use of treatment more than 4 hr. per day		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients in non invasive mechanical ventilation and affiliated by the respiratory centre of the East of Denmark
registered in telemedical solution in the period from 01.01.2020 to 04.01.2022
Age above 18 years

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic respiratory failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet Glostrup		Glostrup Municipality		2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39575944	Derived	Staehr-Rye AK, Irlind TO, Funderskov K, Gatke MR, Kuchen SHL. Adherence to long-term non-invasive positive airway pressure therapy. Dan Med J. 2024 Oct 25;71(11):A04240290. doi: 10.61409/A04240290.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases